Therapeutic Cell Cryostorage for Standard of Care and Newer Advanced Therapies
CellSecure Bio delivers reliable cryostorage for therapeutic cells. These cell-based therapies are stored in vapor-phase LN2 at -190°C to protect their long-term viability. Therapeutic cells, including minimally manipulated bone marrow and stem cells, and more than manually manipulated engineered CAR-T cells, TIL cells, and NK cell therapies, are among those highly vulnerable to temperature excursions and handling. Even relatively minor temperature excursions can compromise cell viability and potency.
CellSecure Bio’s infrastructure, quality management systems, and real-time monitoring protect irreplaceable, one-of-a-kind cells and deliver them to the treatment site on demand.
As legacy bone marrow and stem cell programs and newer, advanced immune-based cell therapies expand to treat disease conditions across numerous medical disciplines, the storage of these cellular-based drugs becomes a necessity. These needs span the spectrum from minimally manipulated cellular therapy products to more than minimally manipulated cellular therapy products that fall under the sections 361 and 351 categories of the FDA regulations.
Whether supporting autologous or allogeneic cellular therapies under the 361 or 351 sections of the FDA regulations, validated controlled environments are needed to maintain the long-term viability of stored cellular therapy products and mitigate the risk of loss of viability and potency of these one-of-a-kind drugs.
Therapeutic cell products often represent patient-specific personalized treatments that cannot be replaced. Autologous therapies require a strict chain of custody and controlled handling to ensure the therapy reaches the right patient.
Our team understands that every storage decision directly impacts:
We provide validated storage environments including:
Our team understands the unique handling, storage, and operational requirements of therapeutic cell products. From validated infrastructure to comprehensive quality systems, we provide the reliability and operational support organizations need to confidently store their most critical cellular therapies.
Located adjacent to the 2nd-busiest airport in the world, our facility provides efficient access to 197 U.S. cities and 69 locations worldwide, supporting time-sensitive shipments of cellular therapy products.
Our strategic location allows us to leverage direct access to an extensive courier network, including TSA-Certified drivers and numerous commercial and cargo airlines for the safe and secure delivery of stored cells.
CellSecure Bio offers a suite of offsite storage solutions. Patient safety, cell viability, rapid retrieval and shipping, and chain of custody are our priorities.
Designed for Cellular Preservation
Every aspect of our cryogenic and ultra-low-temperature storage environments is designed to protect the integrity, availability, and traceability of high-value therapeutic cell products.
Protecting Valuable Therapeutic Assets
Multi-layered security measures, controlled facility access, continuous visual surveillance, monitored alarm systems, and documented chain-of-custody procedures help safeguard clients’ therapeutic cell inventory from unauthorized access or loss.
Prepared for the Unexpected
Our facilities are engineered with redundant power, validated backup equipment, bulk LN2 supply, emergency response procedures, environmental monitoring, and contingency plans to protect valuable biological/clinical materials from unexpected events and equipment failures
Quality Built Into Every Process
Our robust quality management system includes validated SOPs, validated storage environments, continuous environmental monitoring, audit-ready documentation, and controlled operational processes that support GMP, GxP, FDA, and other regulatory requirements.
Complete Traceability from Storage to Retrieval
Every stored unit is accurately tracked through documented inventory management processes that support chain of identity, chain of custody, efficient retrieval, and complete inventory accountability.
Infrastructure That Grows with Clients Pipeline
Flexible cryogenic and ultra-low-temperature storage solutions scale with critical advancements and manufacturing needs without requiring significant capital investment.
Purpose-built cryogenic storage solutions designed around security, temperature control, redundancy, and experienced operational oversight.
